Overview
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the liver to form the active aldophosphamide. It has been used in the treatment of lymphoma and leukemia. Its side effect, alopecia, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Indication
Cyclophosphamide is indicated for the treatment of malignant lymphomas, multiple myeloma, leukemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast. It is also indicated for the treatment of biopsy-proven minimal change nephrotic syndrome in pediatric patients.
Associated Conditions
- Acute Lymphoblastic Leukaemias (ALL)
- Acute Myeloid Leukemia
- Acute monocytic leukemia
- Adenocarcinoma of the Ovaries
- Breast Cancer
- Burkitt Lymphoma
- Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia (CML)
- Hodgkins Disease (HD)
- Lung Cancer
- Lupus
- Lymphocytic Lymphomas
- Lymphoma
- Multiple Myeloma (MM)
- Multiple Sclerosis
- Nephrotic syndrome with lesion of minimal change glomerulonephritis
- Non-Hodgkin's Lymphoma (NHL)
- Retinoblastoma
- Advanced Alibert-Bazin syndrome
- Chronic Granulocytic Leukemias
- Disseminated Neuroblastoma (NB)
- Histiocytic lymphoma
- Mixed-cell type lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/09 | Not Applicable | Not yet recruiting | |||
2025/07/04 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | PETHEMA Foundation | ||
2025/06/26 | Phase 1 | Not yet recruiting | |||
2025/06/25 | Phase 1 | Not yet recruiting | |||
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/06/17 | Phase 1 | Not yet recruiting | Peking University Cancer Hospital & Institute | ||
2025/06/11 | Phase 2 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2025/06/11 | Phase 2 | Not yet recruiting | Vandana Abramson | ||
2025/06/11 | Phase 2 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 10019-957 | INTRAVENOUS, ORAL | 2 g in 100 mL | 10/25/2014 | |
| Baxter Healthcare Corporation | 10019-956 | INTRAVENOUS, ORAL | 1 g in 50 mL | 10/25/2014 | |
| AuroMedics Pharma LLC | 55150-271 | INTRAVENOUS | 1 g in 5 mL | 9/8/2021 | |
| STI Pharma LLC | 54879-021 | ORAL | 25 mg in 1 1 | 1/12/2024 | |
| Sandoz Inc. | 0781-3233 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 12/22/2021 | |
| Civica, Inc. | 72572-087 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 7/31/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-618 | ORAL | 25 mg in 1 1 | 2/17/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1240 | INTRAVENOUS, ORAL | 2 g in 100 mL | 11/3/2023 | |
| Long Grove Pharmaceuticals, LLC | 81298-8110 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 11/10/2023 | |
| NorthStar RxLLC | 72603-104 | INTRAVENOUS, ORAL | 500 mg in 25 mL | 10/11/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENDOXAN FOR INJECTION 500 mg/vial | SIN01748P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 6/9/1988 | |
| CYCRAM FOR INJECTION 1 g/vial | SIN10355P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 11/3/1998 | |
| ENDOXAN TABLET 50 mg | SIN00929P | TABLET, SUGAR COATED | 50 mg | 5/9/1988 | |
| ENDOXAN FOR INJECTION 1 g/vial | SIN01747P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 6/9/1988 | |
| ENDOXAN FOR INJECTION 200 mg/vial | SIN00930P | INJECTION, POWDER, FOR SOLUTION | 200 mg/vial | 5/9/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cyclophosphamide Capsules | 国药准字H20233047 | 化学药品 | 胶囊剂 | 1/10/2023 | |
| Cyclophosphamide Capsules | 国药准字H20233046 | 化学药品 | 胶囊剂 | 1/10/2023 | |
| Cyclophosphamide for Injection | 国药准字H32020856 | 化学药品 | 注射剂 | 8/21/2020 | |
| Cyclophosphamide for Injection | 国药准字HJ20160468 | 化学药品 | 注射剂 | 6/8/2021 | |
| Cyclophosphamide for Injection | 国药准字H20093392 | 化学药品 | 注射剂 | 10/10/2023 | |
| Cyclophosphamide for Injection | 国药准字H20023036 | 化学药品 | 注射剂 | 8/21/2020 | |
| Cyclophosphamide for Injection | 国药准字H14023686 | 化学药品 | 注射剂 | 8/25/2020 | |
| Cyclophosphamide for Injection | 国药准字H20244714 | 化学药品 | 注射剂 | 8/20/2024 | |
| Cyclophosphamide for Injection | 国药准字H32020857 | 化学药品 | 注射剂 | 8/21/2020 | |
| Cyclophosphamide for Injection | 国药准字H32026196 | 化学药品 | 注射剂 | 8/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 1000 mg powder for injection vial | 361545 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 1000 mg powder for injection vial | 361548 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 500 mg powder for injection vial | 361555 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 500 mg powder for injection vial | 361544 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 2000 mg powder for injection vial | 361558 | Medicine | A | 3/7/2022 | |
| CYCLOPHOSPHAMIDE ACCORD cyclophosphamide (as monohydrate) 2000 mg powder for injection vial | 361547 | Medicine | A | 3/7/2022 |
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